US20090082732A1 - Tip shield for needle stick prevention - Google Patents
Tip shield for needle stick prevention Download PDFInfo
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- US20090082732A1 US20090082732A1 US11/861,085 US86108507A US2009082732A1 US 20090082732 A1 US20090082732 A1 US 20090082732A1 US 86108507 A US86108507 A US 86108507A US 2009082732 A1 US2009082732 A1 US 2009082732A1
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- needle
- tip
- shaft
- tip shield
- housing
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/06—Body-piercing guide needles or the like
- A61M25/0606—"Over-the-needle" catheter assemblies, e.g. I.V. catheters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/06—Body-piercing guide needles or the like
- A61M25/0612—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
- A61M25/0618—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders having means for protecting only the distal tip of the needle, e.g. a needle guard
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/06—Body-piercing guide needles or the like
- A61M25/0612—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
- A61M25/0631—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders having means for fully covering the needle after its withdrawal, e.g. needle being withdrawn inside the handle or a cover being advanced over the needle
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
- A61M5/321—Means for protection against accidental injuries by used needles
- A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
- A61M5/3273—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel freely sliding on needle shaft without connection to syringe or needle
Definitions
- vascular access systems are used for communicating fluid with the vascular system of patients and may include one or more vascular access devices.
- catheters are used for infusing fluid, such as saline solution, various medicaments, and/or total parenteral nutrition, into a patient, withdrawing blood from a patient, and/or monitoring various parameters of the patient's vascular system.
- Intravenous (IV) catheter assemblies are among the various types of vascular access systems, and over-the-needle peripheral IV catheters are a common IV catheter configuration.
- an over-the-needle catheter is mounted over an introducer needle having a sharp distal tip.
- the introducer needle is generally a hypodermic needle forming a part of a needle assembly to help guide the needle and to facilitate its cooperation with the catheter.
- At least the inner surface of the distal portion of the catheter tightly engages the outer surface of the needle to prevent peelback of the catheter and thus facilitates insertion of the catheter into the blood vessel.
- the catheter and the introducer needle are assembled so that the distal tip of the introducer needle extends beyond the distal tip of the catheter with the bevel of the needle facing up away from the patient's skin.
- the catheter and introducer needle are generally inserted at a shallow angle through the patient's skin into a blood vessel.
- the clinician In order to verify proper placement of the needle and/or catheter in the blood vessel, the clinician generally confirms that there is “flashback” of blood in a flashback chamber, which is generally associated with a needle assembly. Once proper placement of the distal tip of the catheter into the blood vessel is confirmed, the clinician may apply pressure to the blood vessel by pressing down on the patient's skin over the blood vessel distal of the introducer needle and the catheter. This finger pressure occludes the vessel, minimizing further blood flow through the introducer needle and the catheter.
- a needle tip shield includes a housing, a sleeve, or other similar device that is designed such that when the needle is withdrawn from the patient, the needle tip will be trapped/captured within the needle tip shield.
- the purpose of the needle tip shield is to house the tip of the needle in a secure location, thereby reducing the possibility of needle sticks when the needle and needle tip shield are separated properly from the catheter, which is left in place to provide intravenous access to the patient.
- the separation of the needle assembly from the catheter portions of the catheter assembly presents numerous potential hazards to the clinicians and others in the area. As indicated above, there is a risk of accidental needle sticks if the needle tip is not secured properly in a needle tip shield. Additionally, because the needle has been in contact with blood in the patient's vasculature, blood is often present on the exterior of the needle and is often present inside the lumen of the needle. As the needle is withdrawn, there is a risk that this blood will drip from the needle tip or come into contact with other surfaces to expose clinicians and equipment to blood. The present disclosure presents systems and methods to significantly limit and/or prevent needle sticks, and in some implementations, blood exposure.
- a vascular access system within the scope of the present invention includes a hypodermic needle, a tip shield, and a housing.
- the needle includes a needle shaft that terminates at a needle tip.
- the tip shield includes an enclosure defining a chamber.
- the enclosure includes at least one side wall configured to slidably engage the needle shaft, a closed distal end, and a proximal end slidably engaging the needle shaft. Accordingly, the tip shield may be disposed at an angle with respect to the needle when the needle extends through both the side wall and the proximal end of the tip shield.
- the housing of the vascular access system defines a passageway with respective proximal and distal openings through which the needle slidably extends.
- the proximal opening of the housing releasably retains the tip shield in the passageway.
- at least one of the needle and the tip shield are adapted to prevent the needle shaft from being completely withdrawn from the tip shield.
- the tip shield is adapted to secure the needle tip in the chamber upon withdrawal of the needle tip into the chamber.
- vascular access systems within the scope of the present invention include a needle having an enlarged shaft region proximate to the needle tip.
- the enlarged shaft region cooperates with and engages an opening in the proximal end of the tip shield adapted to slidably engage the needle shaft without allowing the enlarged region to pass proximally through the opening.
- some implementations may include a tip shield having an elongate hollow body defining the chamber and a needle shaft port, which may be in a side wall of the elongate body.
- the needle shaft extends through the opening in the proximal end of the tip shield and the needle shaft port when the needle is disposed in the housing, which disposes the tip shield at an angle with the needle shaft.
- the opening in the proximal end of the tip shield may be configured as a pivot hole that engages the enlarged shaft region during proximal movement of the needle relative to the housing and further proximal movement of the needle relative to the housing causes the tip shield to pivot at the pivot hole drawing the needle tip into and through the needle shaft port and into the chamber.
- FIG. 1 is an exploded perspective view of an exemplary extravascular system incorporating multiple exemplary vascular access devices.
- FIG. 2 is a cross-sectional view of a portion of an exemplary extravascular system.
- FIG. 3 is a cross-sectional view of a portion of a vascular access system showing an exemplary relationship between a housing, a tip shield, and a needle.
- FIG. 4 is a cross-sectional view of the system of FIG. 3 shown with the needle further withdrawn from the housing.
- FIG. 5 is a cross-sectional view of the system of FIG. 3 shown with the needle completely withdrawn from the housing and the tip shield enclosing the needle tip.
- FIG. 6 is a schematic cross-sectional of a portion of an exemplary extravascular system.
- FIG. 7 is a top plan view of a tip shield shown in an unformed stage.
- FIG. 8 is a perspective view of the tip shield of FIG. 7 shown in a partially-formed stage.
- FIG. 9 a perspective view of the tip shield of FIG. 7 shown in a formed stage.
- FIG. 10 is an exploded perspective view of an alternative tip shield molded from a plastic material.
- FIG. 11 is a top plan view of a tip shield shown in an unformed stage.
- FIG. 12 is a perspective view of the tip shield of FIG. 11 shown in a formed stage.
- FIG. 13 is a cross-sectional view of another embodiment of the tip shield of the present invention.
- the perspective view illustrates an example of an extravascular system 10 , or vascular access system, including multiple vascular access devices 12 .
- the extravascular system 10 includes a catheter assembly 14 and a needle assembly 16 .
- the catheter assembly 14 has a proximal end 20 and a distal end 22 and includes a catheter 24 having an opening 28 at the distal end 22 of the catheter assembly 14 and a catheter hub 26 disposed at the proximal end 20 of the catheter assembly 14 .
- the catheter assembly 14 also defines a lumen 30 extending from the proximal end 20 to the distal end 22 .
- Proximal end 20 of catheter assembly 14 may be configured in any suitable manner to facilitate its cooperation with other vascular access devices. Two exemplary configurations are illustrated in FIG. 1 . Shown in solid lines in FIG. 1 , the catheter assembly proximal end 20 may be configured with positioning ridges and grooves 32 adapted to coordinate with similar features on adjoining devices.
- the positioning ridges and grooves 32 are examples of coupling systems that may be used to position and/or retain another vascular access device, such as adapters, flow control plugs, dead-ender caps, or other devices (not shown), attached to the catheter hub 26 in a desired orientation.
- Other suitable coupling and positioning systems may be used. For example, traditional Luer lock features may be included, which may be male or female Luer lock configurations.
- FIG. 1 Two exemplary configurations are illustrated in FIG. 1 . Shown in solid lines in FIG. 1 , the catheter assembly proximal end 20 may be configured with positioning ridges and grooves 32 adapted to coordinate with similar features on adjoining devices.
- the catheter assembly 14 may optionally be configured with an activating housing 34 adapted to cooperate with particular aspects of the present vascular access systems.
- the activating housing 34 will be described in greater detail below, including at least with reference to FIG. 3 .
- the activating housing 34 is one example of a housing 36 within the scope of the present disclosure.
- the vascular access system 10 includes a needle assembly 16 includes a hypodermic needle 40 having a needle shaft 42 adapted to extend through the lumen 30 of the catheter assembly 14 .
- the needle tip 44 and other aspects of the needle 40 are obscured in FIG. 1 by the position of the tip shield 60 and will be illustrated and described in connection with subsequent figures.
- the illustrated needle assembly 16 includes a needle hub 46 , which may be provided in some implementations to facilitate the insertion, removal, and control of the needle 40 and the needle assembly 16 generally.
- the proximal end of the needle assembly 16 may be adapted to cooperate with yet additional vascular access devices 12 , such as a flow control plug 48 as illustrated in FIG. 1 .
- needle assembly 16 illustrated in FIG. 1 is configured for use with the catheter assembly 14
- other needle assemblies and vascular access systems within the scope of the present invention may include hypodermic needles (not shown) adapted for other applications.
- the needle assembly 16 may or may not include the needle hub 46 of the configuration illustrated.
- the vascular access systems of the present disclosure and invention may be adapted for use in injections rather than in cooperation with catheters.
- FIG. 1 further illustrates that the extravascular system 10 may include an optional adapter housing 50 .
- the adapter housing 50 when included, may be configured to cooperate with the tip shield 60 , such as to accommodate the tip shield 60 during use of the extravascular system 10 and to activate the tip shield 60 when the needle 40 is being withdrawn from the catheter assembly 14 .
- the adapter housing 50 is illustrated schematically in FIG. 1 representative of the variety of configurations the adapter housing may take in cooperating with aspects of the needle assembly 16 and the catheter housing 14 .
- the distal end 52 of the adapter housing 50 may be configured with Luer lock features (not shown) to cooperate with mating Luer lock features on the catheter hub 26 .
- the proximal end 54 of the adapter housing 50 may be adapted to coordinate with the needle hub 46 or other aspect of the needle assembly 16 .
- the adapter housing 50 is yet another example of a suitable housing 36 within the scope of the present disclosure.
- the needle tip 44 is illustrated as being housed within the tip shield 60 .
- the tip shield 60 shown in FIG. 1 is representative of needle shield 60 within the scope of the present disclosure.
- the term tip shield 60 shield refers to a structure that is adapted to be positioned adjacent to the needle tip 44 when the needle tip has been withdrawn, such as withdrawn from the catheter assembly 14 or a patient's vascular system, to encapsulate the needle tip 42 .
- FIG. 2 provides an illustrative cross-sectional view of a portion of the extravascular system 10 , including the catheter assembly 14 , the adapter housing 50 , and the needle assembly 16 .
- the catheter assembly 14 and the adapter housing 50 are adapted to associate proximal end 20 to distal end 52 .
- the proximal end of the adapter housing 50 associates with the distal end of the needle hub 46 .
- the adapter housing 50 defines a passageway 54 having a proximal opening 56 and a distal opening 58 .
- the adapter housing 50 accommodates the tip shield 60 within the passageway 54 .
- the proximal opening 56 of the housing 50 is configured to releseably retain the tip shield 60 within the housing.
- the retention of the tip shield 60 may be accomplished by disposing the side walls of the proximal opening 56 close enough together to create a frictional fit between the tip shield 60 and the proximal opening of the housing, as illustrated.
- Other suitable configurations may be utilized to releasably retain the tip shield 60 in the housing 50 , such as disposing a yielding finger or other extension member into the path of the proximal opening 56 that allows the tip shield 60 to pass only under a certain minimum force.
- the releasable retention of the tip shield 60 may be implemented to limit or prevent the inadvertent separation of the needle assembly from the catheter assembly 14 .
- the releasable retention of the tip shield 60 may be configured to assist in the activation or transition of the tip shield from a use position (as seen in FIG. 2 ) to a protection position (as seen in FIG. 1 ).
- FIG. 2 further illustrates that extravascular system 10 may include one or more blood stabilizing materials 38 to further limit the risk of blood exposure.
- the blood stabilizing material 38 is disposed inside the passageway 54 of the housing 50 . Additionally or alternatively, blood stabilizing materials may be disposed inside or outside the adapter housing 50 , inside and/or outside the tip shield 60 , or in any other suitable location to control the spillage or flow of blood.
- the blood stabilizing material 38 is shown schematically to represent the variety of manners in which such material may be incorporated into the present vascular access systems and devices.
- the blood stabilizing material 38 may be a coagulant, an absorbent, or another material for stabilizing the blood to reduce the exposure risk.
- the blood stabilizing material 38 may be a liquid, a solid, a gel, a powder, granular, or any other consistency appropriate for its use.
- the blood stabilizing material 38 may be disposed in a porous membrane or container (not shown) that allows the blood to enter while preventing the exit of the blood stabilizing material 38 .
- the risk of blood being splattered is significantly reduced and the exposure risk is still further minimized due to the stability of the blood (i.e., being coagulated or absorbed, the blood does not contaminate other objects or persons).
- the clinician is then left with a single, defined source of blood exposure risk at a distal exterior surface of the needle tip shield 60 .
- the implementation of blood stabilizing material 38 together with the housing 36 configured to allow the tip shield to close before the needle 40 is completely withdrawn may further reduce the risk of blood exposure.
- the housing 36 may be adapted to allow the tip shield 60 to close or otherwise entrap the needle tip 44 before the needle is fully withdrawn.
- FIG. 2 provides an exemplary illustration of a tip shield 60 including needle trap means configured to allow the needle shaft 42 to slide within the trap means while securing the needle tip 44 once it is withdrawn into the tip shield.
- the tip shield 60 may include an enclosure 62 including at least one side wall 64 , a closed distal end 66 , and a proximal end 68 .
- the proximal end may be adapted to slidingly engage the needle shaft 42 , such as through an opening (not shown in FIG. 2 ).
- at least a portion 64 of the side wall of the enclosure 62 may be adapted to slidingly engage the needle shaft 42 .
- a side wall may be provided with a needle shaft port 72 adapted to slidingly engage the needle shaft 42 .
- At least one of the needle 40 and the tip shield 60 may be configured to retain the needle.
- the needle shaft 42 may be provided with an enlarged shaft region 74 (seen in FIG. 3 ) proximate the needle tip 44 or the needle tip itself and the opening in the proximal end 68 of the enclosure 62 may be configured to prevent the complete withdrawal of the needle tip 44 from the tip shield 60 in the proximal direction.
- the closed distal end 66 of the tip shield 60 prevents distal exit of the needle tip 44 from the tip shield 60 once the needle tip is disposed within the chamber 76 defined by the enclosure 62 .
- the tip shield 60 is configured to allow the needle shaft to extend through a sidewall 64 of the enclosure 62 . Accordingly, with the needle shaft extending through the proximal end of the enclosure and the sidewall of the enclosure, the needle shaft is disposed at an angle with respect to the needle shaft. Depending on the configuration of the needle shaft port 72 , the angle between the needle shaft and the tip shield may vary. One exemplary relationship is shown in FIG. 2 .
- FIGS. 3-5 and 13 collectively, a cross-sectional view of a needle assembly 16 and a housing 36 are illustrated having the needle tip 44 and the tip shield 60 in various states of relationship with the housing 36 .
- the housing 36 is representative of both an activating housing 34 as may be part of a catheter assembly 14 and an adapter housing 50 , as well as other housing configurations that may be implemented.
- One exemplary manner through which the present tip shields 60 and vascular access systems 10 reduce and/or prevent needle sticks is illustrated in FIGS. 3-5 .
- Other suitable methods and configurations may similarly be used implementing the principles of the present disclosure.
- the tip shield 60 may be retained on the needle shaft 42 through use of a tether (not shown) coupled to the tip shield and the needle hub 46 where the tether is dimensioned to be shorter than the needle shaft.
- FIG. 3 illustrates an exemplary relationship between the housing 36 , the tip shield 60 , and the needle 40 when the needle is being withdrawn but before the enlarged shaft region 74 has entered the tip shield.
- the needle tip 44 is being withdrawn proximally and is positioned adjacent the distal opening 58 of the housing 36 .
- the needle shaft 42 extends through the proximal opening 56 of the housing 36 , the proximal end 68 of the tip shield 60 , and the sidewall 64 of the tip shield.
- the needle 40 is shown being further withdrawn in the proximal direction.
- the enlarged shaft region 74 here illustrated as a ferrule, near the needle tip 42 has passed through the sidewall 64 of the tip shield and is shown engaged with the proximal end 68 of the tip shield. It is noted that the enlarged shaft region 74 may be provided by a ferrule or by other means. As the enlarged shaft region 74 engages the proximal end of the tip shield, the needle shaft is no longer able to slide through the tip shield and the tip shield position changes from the disposition shown in FIG. 3 . As the needle is continually moved proximally relative to the housing, the needle shaft 42 and the tip shield 60 will try to move together.
- the proximal opening 56 of the housing 36 does not allow such movement without first moving the tip shield 60 relative to the needle shaft 42 .
- the tip shield 60 rotates becoming more coaxial with the needle shaft.
- the needle tip 44 is pressed further into the chamber 76 of the tip shield 60 .
- the length of the tip shield 60 and the distance from the enlarged shaft region 74 to the needle tip 44 may be coordinated to allow the needle tip to be seated in or received by the tip shield. Any suitable length may be used while shorter lengths may be preferred for the convenience of the users and the costs of materials.
- the needle shaft port 72 and the opening in the proximal end 68 may be configured to allow some movement of the needle shaft to accommodate the rotation of the tip shield relative to the needle shaft.
- the opening in the proximal end of the tip shield may be configured as a slot having sufficiently narrow width to retain the needle tip in the chamber 76 and a length sufficient to accommodate the rotation of the tip shield.
- the needle shaft port 72 or other opening in the sidewall 64 of the tip shield may be sized to allow such movement.
- the tip shield 60 continues to move relative to the needle shaft to a final position in which the needle tip 44 is pressed completely through the needle shaft port 72 into the chamber 76 of the tip shield to encapsulate the needle tip 44 , which is best seen in FIG. 5 .
- the tip shield 60 is longer than the length of the needle 42 from the needle tip 44 to the enlarged shaft region 74 .
- the needle tip 44 is fully encased within the tip shield 60 .
- the enlarged shaft region 74 together with the proximal end of the tip shield prevent the needle tip 44 from exiting the tip shield proximally while the closed distal end 66 of the tip shield prevents the need tip from exiting distally.
- the opening in the sidewall 64 is configured to prevent exit of the needle shaft 42 and/or needle tip 44 once the needle tip is drawn into the chamber 76 .
- the releasable retention of the tip shield 60 by the housing 36 may be configured to ensure that the needle tip 44 is completely received into the chamber 76 before the needle is separated from the housing. Such a configuration ensures that the needle tip 44 is not exposed and thereby prevents needle sticks. Additionally, enclosing the needle tip 44 in the tip shield 60 before the needle tip 44 exits the housing may reduce the risk of blood exposure as well.
- FIG. 13 illustrates essentially the same device as illustrated in FIGS. 3-5 , however, the device is provided with a leaf spring 150 .
- Leaf spring 150 biases the tip shield 60 upwardly as the needle is withdrawn.
- the leaf spring 150 simply provides additional force in an upward direction to assure that the needle is ultimately encased within the tip shield 60 .
- FIG. 6 presents a cross-sectional view similar to the view of FIG. 3 .
- FIG. 6 schematically illustrates a housing 36 configured as an activating housing 34 that is formed as part of the catheter assembly 14 , or more particularly as part of the catheter hub 26 .
- the elements and the relative positions of the elements are the same in FIG. 6 as they are in FIG. 3 and little more description is necessary.
- the proximal opening 56 of the activating housing 34 may be configured to releasably retain the tip shield and to cause the tip shield to move into a protecting position that is at least substantially coaxial with the needle shaft.
- FIG. 6 is merely a schematic representation of a catheter hub 26 adapted to cooperate with tip shields of the present disclosure. Other suitable and more developed configurations may be used as well.
- FIGS. 7-12 additional details of the tip shield are provided along with various examples of methods of constructing the tip shield.
- FIGS. 7-9 provide top plan and perspective views of the tip shield 60 at various stages of the manufacturing process.
- the tip shield may be made of any suitable material that is resistant to penetration by a needle tip.
- the tip shield 60 is made from a stamped sheet 80 ( FIG. 7 ) of stainless steel or other suitable, non-corroding metal or plated metal.
- the sheet 80 includes a rectangular body 82 , a dependent proximal disk 84 with a slot 86 or other opening of a length sufficient to allow the tip shield 60 to pivot relative to the needle shaft 42 , as discussed above, and a width to closely slidably receive the shaft 42 of needle 40 but to not pass the enlarged shaft region 74 .
- the sheet 80 further includes a dependent distal disk 88 , a pair of proximal tabs 90 , and a pair of distal tabs 92 .
- the tabs 90 , 92 are optional, but may be used to facilitate the formation of the tip shield 60 , as seen in FIG. 9 .
- the proximal and distal disks may be coupled and joined to the body through other means.
- the body 82 of sheet 80 is rolled to form a substantially cylindrical shape, as seen in FIG. 8 .
- the opposing longitudinal edges 94 and 96 (shown in FIG. 7 ) are brought together and rolled inward into the cylinder forming what may be referred to as having a rounded heart-shaped cross-section.
- the inwardly rolled opposing longitudinal edges are one manner of forming an opening in the sidewall 64 through which the needle shaft 42 may extend.
- the opposing longitudinal edges may form one example of a needle shaft port 72 .
- the longitudinal edges 94 , 96 may be disposed to be touching or at a spacing that is smaller than the diameter of the needle shaft 42 . Accordingly, the needle 40 cannot pass through the needle shaft port 72 without deforming the body 82 of the tip shield 60 .
- the material and thickness thereof from which the sheet 80 is made, material properties, bending/forming geometry, the spacing of the edges 94 , 96 , heat treatment or temper of the material, and contour (sharp, tapered, or rounded) of the edges 94 , 96 can be varied as desired to control resistance due to drag as the needle 40 is drawn through the needle shaft port 72 .
- the needle shaft port 72 may include deforming or biased materials, such as plastics, that allow the needle shaft to move in one direction (e.g. to allow the needle tip to be drawn in to the chamber) but not in the other direction (e.g. to allow the needle tip to be moved out of the chamber).
- deforming or biased materials such as plastics
- the proximal end 68 and distal end 66 of the tip shield are closed by the respective proximal and distal disks 84 and 88 , which may be as seen in FIG. 9 . This may be accomplished by bending the proximal and distal disks 84 , 88 ninety degrees and securing using the proximal and distal tabs 90 , 92 . Additionally or alternatively, the disks 84 , 88 may be secured to the body 82 through other means. As illustrated in FIG. 9 , the tip shield 60 defines a tip-receiving chamber 76 of a length slightly larger than the distance from the enlarged shaft region 74 to the needle tip 44 to receive the needle tip 44 and enlarged shaft region 74 therein.
- the opening in the proximal end 68 of the tip shield 60 is illustrated as a relatively narrow slot 86 , the opening may be configured in any suitable manner.
- the opening in the proximal end 68 and/or the enlarged shaft region 74 may be configured to facilitate the passage of the enlarged shaft region distally and to retain or prevent the enlarged shaft region during proximal movement.
- the construction or assembly of the needle assembly 16 may be facilitated through strategic order of operations, such as inserting the needle in the reverse direction so that the enlarged shaft region does not have to pass through the tip shield in a distal direction.
- Other suitable methods for assembling the components of the present disclosure are available.
- an exploded perspective view of an alternative tip shield 60 that includes a body 102 , a proximal end cap 104 , and a distal end cap 106 each molded from a suitable medical grade plastic material.
- the body 102 is extruded or otherwise formed to provide a hollow cylinder 108 of the substantially cylindrical construction illustrated.
- the substantially cylindrical cross-section includes an opening in the sidewall thereof, which may be provided by a pair of opposing longitudinal edges 110 .
- the plastic tip shield may be molded to provide a more customized needle shaft port 73 . Due to the flexibility and customizability of plastics, a variety of options may be available for use of plastic as tip shields. For example, the plastic materials may be adapted to provide a better seal against re-emergence of the needle tip and/or to facilitate the operation of the present extravascular systems 10 .
- the proximal end 68 and the distal end 66 of the tip shield may be capped by adhesively or ultrasonically affixing the proximal and distal end caps 104 and 106 thereto.
- the body 102 may be constructed of two halves which are joined together by sonic welding, adhesives, snap fitting, or any other attachment mechanism.
- the plastic material and thickness(es) of the material from which the body 102 is made, material properties, bending/forming geometry, the spacing between edges, any filler materials added to the plastic material, and the contour (sharp, tapered, or rounded) of the edges can be varied as desired to control resistance due to drag as the needle 40 is drawn through the valve needle shaft port 73 .
- FIGS. 11 and 12 provide a schematic illustration of yet another variation on the inventive concepts described herein.
- FIG. 11 is comparable to FIG. 7 illustrating that the tip shield 60 may be formed from a sheet 80 of metal or other suitable material.
- the body 82 of the tip shield 60 shown in FIG. 11 includes shaped regions 112 adjacent the proximal end cap 104 .
- FIG. 12 which illustrates the tip shield 60 formed from the sheet 80 of FIG. 11 , it can be seen that the shaped regions 112 cooperate to form an enlarged opening 114 in the needle shaft port 72 .
- the enlarged opening 114 may be sized to reduce the frictional resistance against movement of the needle shaft in the needle shaft port 72 .
- the shaped regions 112 may be configured in any suitable manner to create an enlarged opening 114 suitable for the needle assembly being used (e.g., the enlarged opening 114 may be larger for larger diameter needle shafts).
- the tip shields can be used to protect the tip of any type of sharp, including a cannula in an IV catheter, the tip of a stylet in a long anesthesia needle, a hypodermic needle, surgical blade and other such medical devices.
- the cross-section of the tip shield can be of other shapes such as square, rectangular, triangular, oval, polygonal, and the like.
- the needle shaft port in the tip shield body can be formed by slitting a pliable tube.
- the needle shaft port may be held open by a tab or a post-like feature, such as adjacent to the proximal end of the tip shield.
- the tab or post-like feature may be used in connection with any of the tip shields described above and may be associated with the housing 36 or other component of the vascular access system.
- the use of a tab feature to hold the needle shaft port open may reduce the frictional drag on the needle shaft as it is being withdrawn and may enable the tip shield to more completely seal once the tip is received in the chamber and the tab feature is disengaged from the tip shield allowing the needle shaft port to close.
- the enlarged shaft region of the needle may be non-symmetrical and/or may be formed other than by crimping the shaft or affixing a ferrule. Moreover, the enlarged shaft region can be retained to prevent proximal movement beyond the tip shield proximal end by means other than the restricted width of the slot.
- the means for activating the tip shield may be varied in any suitable manner.
- the needle tip in addition to or as an alternative to the restricted opening of the housing and cooperating inclined slope (see FIGS. 2-6 ), the needle tip can be pressed or introduced into the chamber of the tip shield by pressure from a biasing member encouraging the tip shield towards the needle shaft.
Abstract
Description
- This disclosure relates generally to vascular access systems and methods, including hypodermic needles, needle assemblies, catheter assemblies, and devices used with catheter assemblies. Generally, vascular access systems are used for communicating fluid with the vascular system of patients and may include one or more vascular access devices. For example, catheters are used for infusing fluid, such as saline solution, various medicaments, and/or total parenteral nutrition, into a patient, withdrawing blood from a patient, and/or monitoring various parameters of the patient's vascular system.
- Intravenous (IV) catheter assemblies are among the various types of vascular access systems, and over-the-needle peripheral IV catheters are a common IV catheter configuration. As its name implies, an over-the-needle catheter is mounted over an introducer needle having a sharp distal tip. The introducer needle is generally a hypodermic needle forming a part of a needle assembly to help guide the needle and to facilitate its cooperation with the catheter. At least the inner surface of the distal portion of the catheter tightly engages the outer surface of the needle to prevent peelback of the catheter and thus facilitates insertion of the catheter into the blood vessel. The catheter and the introducer needle are assembled so that the distal tip of the introducer needle extends beyond the distal tip of the catheter with the bevel of the needle facing up away from the patient's skin. The catheter and introducer needle are generally inserted at a shallow angle through the patient's skin into a blood vessel.
- In order to verify proper placement of the needle and/or catheter in the blood vessel, the clinician generally confirms that there is “flashback” of blood in a flashback chamber, which is generally associated with a needle assembly. Once proper placement of the distal tip of the catheter into the blood vessel is confirmed, the clinician may apply pressure to the blood vessel by pressing down on the patient's skin over the blood vessel distal of the introducer needle and the catheter. This finger pressure occludes the vessel, minimizing further blood flow through the introducer needle and the catheter.
- The clinician may then withdraw the introducer needle from the catheter. The introducer needle may be withdrawn into a needle tip shield or needle shield that covers the needle tip and prevents accidental needle sticks. In general, a needle tip shield includes a housing, a sleeve, or other similar device that is designed such that when the needle is withdrawn from the patient, the needle tip will be trapped/captured within the needle tip shield. The purpose of the needle tip shield is to house the tip of the needle in a secure location, thereby reducing the possibility of needle sticks when the needle and needle tip shield are separated properly from the catheter, which is left in place to provide intravenous access to the patient.
- The separation of the needle assembly from the catheter portions of the catheter assembly presents numerous potential hazards to the clinicians and others in the area. As indicated above, there is a risk of accidental needle sticks if the needle tip is not secured properly in a needle tip shield. Additionally, because the needle has been in contact with blood in the patient's vasculature, blood is often present on the exterior of the needle and is often present inside the lumen of the needle. As the needle is withdrawn, there is a risk that this blood will drip from the needle tip or come into contact with other surfaces to expose clinicians and equipment to blood. The present disclosure presents systems and methods to significantly limit and/or prevent needle sticks, and in some implementations, blood exposure.
- The systems and methods of the present disclosure have been developed in response to problems and needs in the art that have not yet been finally resolved by currently available vascular access systems and methods. Thus, these systems and methods are developed to provide safer vascular access systems, methods of manufacturing the same, and methods of using the same to reduce needle sticks.
- A vascular access system within the scope of the present invention includes a hypodermic needle, a tip shield, and a housing. The needle includes a needle shaft that terminates at a needle tip. The tip shield includes an enclosure defining a chamber. The enclosure includes at least one side wall configured to slidably engage the needle shaft, a closed distal end, and a proximal end slidably engaging the needle shaft. Accordingly, the tip shield may be disposed at an angle with respect to the needle when the needle extends through both the side wall and the proximal end of the tip shield. The housing of the vascular access system defines a passageway with respective proximal and distal openings through which the needle slidably extends. The proximal opening of the housing releasably retains the tip shield in the passageway. Through a variety of possible implementations, at least one of the needle and the tip shield are adapted to prevent the needle shaft from being completely withdrawn from the tip shield. Additionally, the tip shield is adapted to secure the needle tip in the chamber upon withdrawal of the needle tip into the chamber.
- In some implementations, vascular access systems within the scope of the present invention include a needle having an enlarged shaft region proximate to the needle tip. The enlarged shaft region cooperates with and engages an opening in the proximal end of the tip shield adapted to slidably engage the needle shaft without allowing the enlarged region to pass proximally through the opening. Additionally or alternatively, some implementations may include a tip shield having an elongate hollow body defining the chamber and a needle shaft port, which may be in a side wall of the elongate body. In such implementations, the needle shaft extends through the opening in the proximal end of the tip shield and the needle shaft port when the needle is disposed in the housing, which disposes the tip shield at an angle with the needle shaft. The opening in the proximal end of the tip shield may be configured as a pivot hole that engages the enlarged shaft region during proximal movement of the needle relative to the housing and further proximal movement of the needle relative to the housing causes the tip shield to pivot at the pivot hole drawing the needle tip into and through the needle shaft port and into the chamber.
- These and other features and advantages of the present disclosure may be incorporated into certain embodiments and will become more fully apparent from the following description and appended claims, or may be learned by the practice of the methods and use of the systems as set forth hereinafter. The present disclosure does not require that all the advantageous features and all the advantages described herein be incorporated into every embodiment.
- In order that the manner in which the above-recited and other features and advantages of the invention are obtained will be readily understood, a more particular description will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. These drawings depict only typical embodiments and are not therefore to be considered to limit the scope of the present invention.
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FIG. 1 is an exploded perspective view of an exemplary extravascular system incorporating multiple exemplary vascular access devices. -
FIG. 2 is a cross-sectional view of a portion of an exemplary extravascular system. -
FIG. 3 is a cross-sectional view of a portion of a vascular access system showing an exemplary relationship between a housing, a tip shield, and a needle. -
FIG. 4 is a cross-sectional view of the system ofFIG. 3 shown with the needle further withdrawn from the housing. -
FIG. 5 is a cross-sectional view of the system ofFIG. 3 shown with the needle completely withdrawn from the housing and the tip shield enclosing the needle tip. -
FIG. 6 is a schematic cross-sectional of a portion of an exemplary extravascular system. -
FIG. 7 is a top plan view of a tip shield shown in an unformed stage. -
FIG. 8 is a perspective view of the tip shield ofFIG. 7 shown in a partially-formed stage. -
FIG. 9 a perspective view of the tip shield ofFIG. 7 shown in a formed stage. -
FIG. 10 is an exploded perspective view of an alternative tip shield molded from a plastic material. -
FIG. 11 is a top plan view of a tip shield shown in an unformed stage. -
FIG. 12 is a perspective view of the tip shield ofFIG. 11 shown in a formed stage. -
FIG. 13 is a cross-sectional view of another embodiment of the tip shield of the present invention. - The presently preferred embodiments of the present disclosure will be best understood by reference to the drawings. It will be readily understood that the components of the present disclosure, as generally described and illustrated in the figures herein, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description, as represented in the figures, is not intended to limit the scope of the claims, but is merely representative of presently preferred embodiments.
- Referring to
FIG. 1 , the perspective view illustrates an example of anextravascular system 10, or vascular access system, including multiplevascular access devices 12. In this example, theextravascular system 10 includes acatheter assembly 14 and aneedle assembly 16. Thecatheter assembly 14 has aproximal end 20 and adistal end 22 and includes acatheter 24 having anopening 28 at thedistal end 22 of thecatheter assembly 14 and acatheter hub 26 disposed at theproximal end 20 of thecatheter assembly 14. Thecatheter assembly 14 also defines alumen 30 extending from theproximal end 20 to thedistal end 22. -
Proximal end 20 ofcatheter assembly 14 may be configured in any suitable manner to facilitate its cooperation with other vascular access devices. Two exemplary configurations are illustrated inFIG. 1 . Shown in solid lines inFIG. 1 , the catheter assemblyproximal end 20 may be configured with positioning ridges andgrooves 32 adapted to coordinate with similar features on adjoining devices. The positioning ridges andgrooves 32 are examples of coupling systems that may be used to position and/or retain another vascular access device, such as adapters, flow control plugs, dead-ender caps, or other devices (not shown), attached to thecatheter hub 26 in a desired orientation. Other suitable coupling and positioning systems may be used. For example, traditional Luer lock features may be included, which may be male or female Luer lock configurations.FIG. 1 further illustrates, in dotted lines, that thecatheter assembly 14 may optionally be configured with an activatinghousing 34 adapted to cooperate with particular aspects of the present vascular access systems. The activatinghousing 34 will be described in greater detail below, including at least with reference toFIG. 3 . The activatinghousing 34 is one example of ahousing 36 within the scope of the present disclosure. - Continuing with
FIG. 1 , thevascular access system 10 includes aneedle assembly 16 includes ahypodermic needle 40 having aneedle shaft 42 adapted to extend through thelumen 30 of thecatheter assembly 14. Theneedle tip 44 and other aspects of theneedle 40 are obscured inFIG. 1 by the position of thetip shield 60 and will be illustrated and described in connection with subsequent figures. The illustratedneedle assembly 16 includes aneedle hub 46, which may be provided in some implementations to facilitate the insertion, removal, and control of theneedle 40 and theneedle assembly 16 generally. The proximal end of theneedle assembly 16 may be adapted to cooperate with yet additionalvascular access devices 12, such as a flow control plug 48 as illustrated inFIG. 1 . - While the
needle assembly 16 illustrated inFIG. 1 is configured for use with thecatheter assembly 14, other needle assemblies and vascular access systems within the scope of the present invention may include hypodermic needles (not shown) adapted for other applications. For example, theneedle assembly 16 may or may not include theneedle hub 46 of the configuration illustrated. Additionally or alternatively, the vascular access systems of the present disclosure and invention may be adapted for use in injections rather than in cooperation with catheters. -
FIG. 1 further illustrates that theextravascular system 10 may include anoptional adapter housing 50. Theadapter housing 50, when included, may be configured to cooperate with thetip shield 60, such as to accommodate thetip shield 60 during use of theextravascular system 10 and to activate thetip shield 60 when theneedle 40 is being withdrawn from thecatheter assembly 14. Theadapter housing 50 is illustrated schematically inFIG. 1 representative of the variety of configurations the adapter housing may take in cooperating with aspects of theneedle assembly 16 and thecatheter housing 14. For example, thedistal end 52 of theadapter housing 50 may be configured with Luer lock features (not shown) to cooperate with mating Luer lock features on thecatheter hub 26. Similarly, theproximal end 54 of theadapter housing 50 may be adapted to coordinate with theneedle hub 46 or other aspect of theneedle assembly 16. Theadapter housing 50 is yet another example of asuitable housing 36 within the scope of the present disclosure. - With continuing reference to
FIG. 1 , theneedle tip 44 is illustrated as being housed within thetip shield 60. Thetip shield 60 shown inFIG. 1 is representative ofneedle shield 60 within the scope of the present disclosure. As used herein, theterm tip shield 60 shield refers to a structure that is adapted to be positioned adjacent to theneedle tip 44 when the needle tip has been withdrawn, such as withdrawn from thecatheter assembly 14 or a patient's vascular system, to encapsulate theneedle tip 42. -
FIG. 2 provides an illustrative cross-sectional view of a portion of theextravascular system 10, including thecatheter assembly 14, theadapter housing 50, and theneedle assembly 16. As seen inFIG. 2 , thecatheter assembly 14 and theadapter housing 50 are adapted to associateproximal end 20 todistal end 52. Additionally, the proximal end of theadapter housing 50 associates with the distal end of theneedle hub 46. Theadapter housing 50 defines apassageway 54 having aproximal opening 56 and adistal opening 58. As shown inFIG. 3 , theadapter housing 50 accommodates thetip shield 60 within thepassageway 54. - Moreover, the
proximal opening 56 of thehousing 50 is configured to releseably retain thetip shield 60 within the housing. The retention of thetip shield 60 may be accomplished by disposing the side walls of theproximal opening 56 close enough together to create a frictional fit between thetip shield 60 and the proximal opening of the housing, as illustrated. Other suitable configurations may be utilized to releasably retain thetip shield 60 in thehousing 50, such as disposing a yielding finger or other extension member into the path of theproximal opening 56 that allows thetip shield 60 to pass only under a certain minimum force. The releasable retention of thetip shield 60 may be implemented to limit or prevent the inadvertent separation of the needle assembly from thecatheter assembly 14. Additionally or alternatively, the releasable retention of thetip shield 60 may be configured to assist in the activation or transition of the tip shield from a use position (as seen inFIG. 2 ) to a protection position (as seen inFIG. 1 ). -
FIG. 2 further illustrates thatextravascular system 10 may include one or moreblood stabilizing materials 38 to further limit the risk of blood exposure. As seen inFIG. 2 , theblood stabilizing material 38 is disposed inside thepassageway 54 of thehousing 50. Additionally or alternatively, blood stabilizing materials may be disposed inside or outside theadapter housing 50, inside and/or outside thetip shield 60, or in any other suitable location to control the spillage or flow of blood. Theblood stabilizing material 38 is shown schematically to represent the variety of manners in which such material may be incorporated into the present vascular access systems and devices. Theblood stabilizing material 38 may be a coagulant, an absorbent, or another material for stabilizing the blood to reduce the exposure risk. Similarly, theblood stabilizing material 38 may be a liquid, a solid, a gel, a powder, granular, or any other consistency appropriate for its use. Theblood stabilizing material 38 may be disposed in a porous membrane or container (not shown) that allows the blood to enter while preventing the exit of theblood stabilizing material 38. - Once the blood has been stabilized by absorption and/or coagulation by contact with the
blood stabilizing material 38, the risk of blood being splattered is significantly reduced and the exposure risk is still further minimized due to the stability of the blood (i.e., being coagulated or absorbed, the blood does not contaminate other objects or persons). The clinician is then left with a single, defined source of blood exposure risk at a distal exterior surface of theneedle tip shield 60. The implementation ofblood stabilizing material 38 together with thehousing 36 configured to allow the tip shield to close before theneedle 40 is completely withdrawn may further reduce the risk of blood exposure. - As suggested, the
housing 36, whether implemented as part of a catheter assembly, as a separate adapter, or as part of a needle assembly, may be adapted to allow thetip shield 60 to close or otherwise entrap theneedle tip 44 before the needle is fully withdrawn.FIG. 2 provides an exemplary illustration of atip shield 60 including needle trap means configured to allow theneedle shaft 42 to slide within the trap means while securing theneedle tip 44 once it is withdrawn into the tip shield. For example, and as illustrated inFIG. 2 , thetip shield 60 may include anenclosure 62 including at least oneside wall 64, a closeddistal end 66, and aproximal end 68. The proximal end may be adapted to slidingly engage theneedle shaft 42, such as through an opening (not shown inFIG. 2 ). Similarly, at least aportion 64 of the side wall of theenclosure 62 may be adapted to slidingly engage theneedle shaft 42. For example, a side wall may be provided with aneedle shaft port 72 adapted to slidingly engage theneedle shaft 42. - To prevent the
needle 40 from being withdrawn proximally from thetip shield 60, thereby exposing theneedle tip 44, at least one of theneedle 40 and thetip shield 60 may be configured to retain the needle. For example, theneedle shaft 42 may be provided with an enlarged shaft region 74 (seen inFIG. 3 ) proximate theneedle tip 44 or the needle tip itself and the opening in theproximal end 68 of theenclosure 62 may be configured to prevent the complete withdrawal of theneedle tip 44 from thetip shield 60 in the proximal direction. Additionally, the closeddistal end 66 of thetip shield 60 prevents distal exit of theneedle tip 44 from thetip shield 60 once the needle tip is disposed within thechamber 76 defined by theenclosure 62. - As will be described in further detail in connection with
FIGS. 7-12 , thetip shield 60 is configured to allow the needle shaft to extend through asidewall 64 of theenclosure 62. Accordingly, with the needle shaft extending through the proximal end of the enclosure and the sidewall of the enclosure, the needle shaft is disposed at an angle with respect to the needle shaft. Depending on the configuration of theneedle shaft port 72, the angle between the needle shaft and the tip shield may vary. One exemplary relationship is shown inFIG. 2 . - Referring now to
FIGS. 3-5 and 13 collectively, a cross-sectional view of aneedle assembly 16 and ahousing 36 are illustrated having theneedle tip 44 and thetip shield 60 in various states of relationship with thehousing 36. As illustrated, thehousing 36 is representative of both an activatinghousing 34 as may be part of acatheter assembly 14 and anadapter housing 50, as well as other housing configurations that may be implemented. One exemplary manner through which the present tip shields 60 andvascular access systems 10 reduce and/or prevent needle sticks is illustrated inFIGS. 3-5 . Other suitable methods and configurations may similarly be used implementing the principles of the present disclosure. As just one example, thetip shield 60 may be retained on theneedle shaft 42 through use of a tether (not shown) coupled to the tip shield and theneedle hub 46 where the tether is dimensioned to be shorter than the needle shaft. -
FIG. 3 illustrates an exemplary relationship between thehousing 36, thetip shield 60, and theneedle 40 when the needle is being withdrawn but before theenlarged shaft region 74 has entered the tip shield. As discussed above, theneedle tip 44 is being withdrawn proximally and is positioned adjacent thedistal opening 58 of thehousing 36. Theneedle shaft 42 extends through theproximal opening 56 of thehousing 36, theproximal end 68 of thetip shield 60, and thesidewall 64 of the tip shield. - Referring now to
FIG. 4 , theneedle 40 is shown being further withdrawn in the proximal direction. Theenlarged shaft region 74, here illustrated as a ferrule, near theneedle tip 42 has passed through thesidewall 64 of the tip shield and is shown engaged with theproximal end 68 of the tip shield. It is noted that theenlarged shaft region 74 may be provided by a ferrule or by other means. As theenlarged shaft region 74 engages the proximal end of the tip shield, the needle shaft is no longer able to slide through the tip shield and the tip shield position changes from the disposition shown inFIG. 3 . As the needle is continually moved proximally relative to the housing, theneedle shaft 42 and thetip shield 60 will try to move together. However, theproximal opening 56 of thehousing 36 does not allow such movement without first moving thetip shield 60 relative to theneedle shaft 42. As illustrated, thetip shield 60 rotates becoming more coaxial with the needle shaft. As theneedle 40 and thetip shield 60 are drawn through theproximal opening 56 of thehousing 36, theneedle tip 44 is pressed further into thechamber 76 of thetip shield 60. The length of thetip shield 60 and the distance from theenlarged shaft region 74 to theneedle tip 44 may be coordinated to allow the needle tip to be seated in or received by the tip shield. Any suitable length may be used while shorter lengths may be preferred for the convenience of the users and the costs of materials. - It should be noted by comparing the illustrations in
FIGS. 3 and 4 that theneedle shaft port 72 and the opening in theproximal end 68 may be configured to allow some movement of the needle shaft to accommodate the rotation of the tip shield relative to the needle shaft. For example, the opening in the proximal end of the tip shield may be configured as a slot having sufficiently narrow width to retain the needle tip in thechamber 76 and a length sufficient to accommodate the rotation of the tip shield. Similarly, theneedle shaft port 72 or other opening in thesidewall 64 of the tip shield may be sized to allow such movement. - As the
needle 40 and thetip shield 60 are further drawn through theproximal opening 56 ofhousing 36, thetip shield 60 continues to move relative to the needle shaft to a final position in which theneedle tip 44 is pressed completely through theneedle shaft port 72 into thechamber 76 of the tip shield to encapsulate theneedle tip 44, which is best seen inFIG. 5 . As illustrated inFIG. 5 , thetip shield 60 is longer than the length of theneedle 42 from theneedle tip 44 to theenlarged shaft region 74. Thus, theneedle tip 44 is fully encased within thetip shield 60. - The
enlarged shaft region 74 together with the proximal end of the tip shield prevent theneedle tip 44 from exiting the tip shield proximally while the closeddistal end 66 of the tip shield prevents the need tip from exiting distally. As will be seen in the discussion ofFIGS. 7-12 , the opening in thesidewall 64 is configured to prevent exit of theneedle shaft 42 and/orneedle tip 44 once the needle tip is drawn into thechamber 76. - The releasable retention of the
tip shield 60 by thehousing 36 may be configured to ensure that theneedle tip 44 is completely received into thechamber 76 before the needle is separated from the housing. Such a configuration ensures that theneedle tip 44 is not exposed and thereby prevents needle sticks. Additionally, enclosing theneedle tip 44 in thetip shield 60 before theneedle tip 44 exits the housing may reduce the risk of blood exposure as well. -
FIG. 13 illustrates essentially the same device as illustrated inFIGS. 3-5 , however, the device is provided with aleaf spring 150.Leaf spring 150 biases thetip shield 60 upwardly as the needle is withdrawn. Theleaf spring 150 simply provides additional force in an upward direction to assure that the needle is ultimately encased within thetip shield 60. -
FIG. 6 presents a cross-sectional view similar to the view ofFIG. 3 .FIG. 6 schematically illustrates ahousing 36 configured as an activatinghousing 34 that is formed as part of thecatheter assembly 14, or more particularly as part of thecatheter hub 26. The elements and the relative positions of the elements are the same inFIG. 6 as they are inFIG. 3 and little more description is necessary. It should be noted that theproximal opening 56 of the activatinghousing 34 may be configured to releasably retain the tip shield and to cause the tip shield to move into a protecting position that is at least substantially coaxial with the needle shaft.FIG. 6 is merely a schematic representation of acatheter hub 26 adapted to cooperate with tip shields of the present disclosure. Other suitable and more developed configurations may be used as well. - Turning now to
FIGS. 7-12 , additional details of the tip shield are provided along with various examples of methods of constructing the tip shield. For example,FIGS. 7-9 provide top plan and perspective views of thetip shield 60 at various stages of the manufacturing process. The tip shield may be made of any suitable material that is resistant to penetration by a needle tip. In the illustrated configuration ofFIGS. 7-9 , thetip shield 60 is made from a stamped sheet 80 (FIG. 7 ) of stainless steel or other suitable, non-corroding metal or plated metal. Thesheet 80 includes arectangular body 82, a dependentproximal disk 84 with aslot 86 or other opening of a length sufficient to allow thetip shield 60 to pivot relative to theneedle shaft 42, as discussed above, and a width to closely slidably receive theshaft 42 ofneedle 40 but to not pass theenlarged shaft region 74. Thesheet 80 further includes a dependentdistal disk 88, a pair ofproximal tabs 90, and a pair ofdistal tabs 92. Thetabs tip shield 60, as seen inFIG. 9 . Alternatively, the proximal and distal disks may be coupled and joined to the body through other means. - The
body 82 ofsheet 80 is rolled to form a substantially cylindrical shape, as seen inFIG. 8 . The opposinglongitudinal edges 94 and 96 (shown inFIG. 7 ) are brought together and rolled inward into the cylinder forming what may be referred to as having a rounded heart-shaped cross-section. The inwardly rolled opposing longitudinal edges are one manner of forming an opening in thesidewall 64 through which theneedle shaft 42 may extend. The opposing longitudinal edges may form one example of aneedle shaft port 72. The longitudinal edges 94, 96 may be disposed to be touching or at a spacing that is smaller than the diameter of theneedle shaft 42. Accordingly, theneedle 40 cannot pass through theneedle shaft port 72 without deforming thebody 82 of thetip shield 60. The material and thickness thereof from which thesheet 80 is made, material properties, bending/forming geometry, the spacing of theedges edges needle 40 is drawn through theneedle shaft port 72. - While opposing
longitudinal edges needle shaft port 72, other suitable configurations may be used. For example, theneedle shaft port 72 may include deforming or biased materials, such as plastics, that allow the needle shaft to move in one direction (e.g. to allow the needle tip to be drawn in to the chamber) but not in the other direction (e.g. to allow the needle tip to be moved out of the chamber). - The
proximal end 68 anddistal end 66 of the tip shield are closed by the respective proximal anddistal disks FIG. 9 . This may be accomplished by bending the proximal anddistal disks distal tabs disks body 82 through other means. As illustrated inFIG. 9 , thetip shield 60 defines a tip-receivingchamber 76 of a length slightly larger than the distance from theenlarged shaft region 74 to theneedle tip 44 to receive theneedle tip 44 andenlarged shaft region 74 therein. - While the opening in the
proximal end 68 of thetip shield 60 is illustrated as a relativelynarrow slot 86, the opening may be configured in any suitable manner. For example, to facilitate assembly of the needle assembly, the opening in theproximal end 68 and/or theenlarged shaft region 74 may be configured to facilitate the passage of the enlarged shaft region distally and to retain or prevent the enlarged shaft region during proximal movement. Additionally or alternatively, the construction or assembly of theneedle assembly 16 may be facilitated through strategic order of operations, such as inserting the needle in the reverse direction so that the enlarged shaft region does not have to pass through the tip shield in a distal direction. Other suitable methods for assembling the components of the present disclosure are available. - Referring to
FIG. 10 , an exploded perspective view of analternative tip shield 60 that includes abody 102, aproximal end cap 104, and adistal end cap 106 each molded from a suitable medical grade plastic material. Thebody 102 is extruded or otherwise formed to provide ahollow cylinder 108 of the substantially cylindrical construction illustrated. The substantially cylindrical cross-section includes an opening in the sidewall thereof, which may be provided by a pair of opposinglongitudinal edges 110. Additionally or alternatively, the plastic tip shield may be molded to provide a more customizedneedle shaft port 73. Due to the flexibility and customizability of plastics, a variety of options may be available for use of plastic as tip shields. For example, the plastic materials may be adapted to provide a better seal against re-emergence of the needle tip and/or to facilitate the operation of the presentextravascular systems 10. - The
proximal end 68 and thedistal end 66 of the tip shield may be capped by adhesively or ultrasonically affixing the proximal anddistal end caps body 102 may be constructed of two halves which are joined together by sonic welding, adhesives, snap fitting, or any other attachment mechanism. The plastic material and thickness(es) of the material from which thebody 102 is made, material properties, bending/forming geometry, the spacing between edges, any filler materials added to the plastic material, and the contour (sharp, tapered, or rounded) of the edges can be varied as desired to control resistance due to drag as theneedle 40 is drawn through the valveneedle shaft port 73. -
FIGS. 11 and 12 provide a schematic illustration of yet another variation on the inventive concepts described herein.FIG. 11 is comparable toFIG. 7 illustrating that thetip shield 60 may be formed from asheet 80 of metal or other suitable material. However, it should be noted that thebody 82 of thetip shield 60 shown inFIG. 11 includes shapedregions 112 adjacent theproximal end cap 104. Referring toFIG. 12 , which illustrates thetip shield 60 formed from thesheet 80 ofFIG. 11 , it can be seen that the shapedregions 112 cooperate to form anenlarged opening 114 in theneedle shaft port 72. Theenlarged opening 114 may be sized to reduce the frictional resistance against movement of the needle shaft in theneedle shaft port 72. Accordingly, the shapedregions 112 may be configured in any suitable manner to create anenlarged opening 114 suitable for the needle assembly being used (e.g., theenlarged opening 114 may be larger for larger diameter needle shafts). - Various modifications to the needle tip shields of the present invention are possible while staying within the same inventive concept. For example, the tip shields can be used to protect the tip of any type of sharp, including a cannula in an IV catheter, the tip of a stylet in a long anesthesia needle, a hypodermic needle, surgical blade and other such medical devices. Additionally, the cross-section of the tip shield can be of other shapes such as square, rectangular, triangular, oval, polygonal, and the like.
- Still additionally or alternatively, the needle shaft port in the tip shield body can be formed by slitting a pliable tube. In some configurations, the needle shaft port may be held open by a tab or a post-like feature, such as adjacent to the proximal end of the tip shield. The tab or post-like feature may be used in connection with any of the tip shields described above and may be associated with the
housing 36 or other component of the vascular access system. The use of a tab feature to hold the needle shaft port open may reduce the frictional drag on the needle shaft as it is being withdrawn and may enable the tip shield to more completely seal once the tip is received in the chamber and the tab feature is disengaged from the tip shield allowing the needle shaft port to close. - Additionally or alternatively, the enlarged shaft region of the needle may be non-symmetrical and/or may be formed other than by crimping the shaft or affixing a ferrule. Moreover, the enlarged shaft region can be retained to prevent proximal movement beyond the tip shield proximal end by means other than the restricted width of the slot.
- As still further variations on the inventive principles of the present application, the means for activating the tip shield may be varied in any suitable manner. For example, in addition to or as an alternative to the restricted opening of the housing and cooperating inclined slope (see
FIGS. 2-6 ), the needle tip can be pressed or introduced into the chamber of the tip shield by pressure from a biasing member encouraging the tip shield towards the needle shaft. - It is believed that the disclosure set forth above encompasses multiple distinct methods and/or apparatus with independent utility. While each of these methods and apparatus has been disclosed in its preferred form, the specific embodiments thereof as disclosed and illustrated herein are not to be considered in a limiting sense as numerous variations are possible. The subject matter of the disclosures includes all novel and non-obvious combinations and sub-combinations of the various elements, features, functions and/or properties disclosed herein. The principles of the present disclosure may be embodied in other specific forms without departing from its structures, methods, or other essential characteristics as broadly described herein, The described embodiments are to be considered in all respects only as illustrative, and not restrictive. The scope of the disclosure is, therefore, not limited by the foregoing description or the following claims, and all changes that come within the meaning and range of equivalency of the foregoing description and/or the following claims are to be embraced within its scope. Similarly, where the description and/or the claims recite “a” or “a first” element or the equivalent thereof, such description should be understood to include incorporation of one or more such elements, neither requiring nor excluding two or more such elements.
- It is believed that the following claims are directed to certain combinations and sub-combinations that correspond to disclosed examples and that are believed to be novel and non-obvious. Other combinations and sub-combinations of features, functions, elements and/or properties may be claimed through amendment of the present claims or presentation of new claims in this or a related application. Such amended or new claims, whether they are directed to a different combination or directed to the same combination, whether different, broader, narrower or equal in scope to the original claims, are also regarded as included within the subject matter of the present disclosure.
Claims (18)
Priority Applications (7)
Application Number | Priority Date | Filing Date | Title |
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US11/861,085 US7713243B2 (en) | 2007-09-25 | 2007-09-25 | Tip shield for needle stick prevention |
AU2008304568A AU2008304568B2 (en) | 2007-09-25 | 2008-09-23 | Tip shield for needle stick prevention |
PCT/US2008/077360 WO2009042583A2 (en) | 2007-09-25 | 2008-09-23 | Tip shield for needle stick prevention |
EP08833298.6A EP2211942B1 (en) | 2007-09-25 | 2008-09-23 | Tip shield for needle stick prevention |
BRPI0817700A BRPI0817700B8 (en) | 2007-09-25 | 2008-09-23 | vascular access system to prevent injury |
CN2008801172402A CN101868269B (en) | 2007-09-25 | 2008-09-23 | Tip shield for needle stick prevention |
ES08833298.6T ES2445793T3 (en) | 2007-09-25 | 2008-09-23 | Tip protector to prevent needle sticks |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
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US11/861,085 US7713243B2 (en) | 2007-09-25 | 2007-09-25 | Tip shield for needle stick prevention |
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US20090082732A1 true US20090082732A1 (en) | 2009-03-26 |
US7713243B2 US7713243B2 (en) | 2010-05-11 |
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US11/861,085 Active 2028-03-16 US7713243B2 (en) | 2007-09-25 | 2007-09-25 | Tip shield for needle stick prevention |
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US (1) | US7713243B2 (en) |
EP (1) | EP2211942B1 (en) |
CN (1) | CN101868269B (en) |
AU (1) | AU2008304568B2 (en) |
BR (1) | BRPI0817700B8 (en) |
ES (1) | ES2445793T3 (en) |
WO (1) | WO2009042583A2 (en) |
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Also Published As
Publication number | Publication date |
---|---|
EP2211942A2 (en) | 2010-08-04 |
EP2211942A4 (en) | 2010-12-22 |
AU2008304568A1 (en) | 2009-04-02 |
EP2211942B1 (en) | 2013-11-13 |
BRPI0817700A2 (en) | 2015-03-31 |
ES2445793T3 (en) | 2014-03-05 |
AU2008304568B2 (en) | 2013-10-17 |
WO2009042583A3 (en) | 2009-06-18 |
BRPI0817700B8 (en) | 2021-06-22 |
BRPI0817700B1 (en) | 2019-02-12 |
WO2009042583A2 (en) | 2009-04-02 |
CN101868269A (en) | 2010-10-20 |
US7713243B2 (en) | 2010-05-11 |
CN101868269B (en) | 2012-11-07 |
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